Cleared Traditional

DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE (K875059) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K875059 · Daig Corp. · Cardiovascular device
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Feb 1988
Decision
65d
Days
Class 2
Risk

K875059 is an FDA 510(k) clearance for the DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Daig Corp. (Minnetonka, US). The FDA issued a Cleared decision on February 12, 1988 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Daig Corp. devices

Submission Details

510(k) Number K875059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date February 12, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LDF Electrode, Pacemaker, Temporary

All 47
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K875059.
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342 · Medtronic Vascular · Oct 1990
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789 · Medtronic Vascular · Dec 1989
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · C.R. Bard, Inc. · Sep 1988
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970 · Medtronic Vascular · Sep 1987
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 1985
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · Cordis Corp. · Sep 1985